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Evaluating AK120 for treating moderate to severe atopic dermatitis

a Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis

Phase 3 Interventional Akeso · NCT06383468

This study is testing if AK120 injections can help people with moderate to severe atopic dermatitis feel better and improve their quality of life.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment420 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAkeso Industry-sponsored
Drugs / interventionsimmunotherapy
Locations59 sites (Beijing, Beijing and 58 other locations)
Trial IDNCT06383468 on ClinicalTrials.gov

What this trial studies

This phase III clinical study is a randomized double-blind, placebo-controlled trial designed to assess the efficacy and safety of AK120 injections in patients suffering from moderate to severe atopic dermatitis. Participants will undergo a screening period followed by a controlled treatment phase, a conversion and maintenance treatment phase, and a safety follow-up period. The study aims to determine how well AK120 can improve symptoms and quality of life for these patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a long-standing diagnosis of moderate to severe atopic dermatitis.

Not a fit: Patients with acute onset of atopic dermatitis or those who have recently participated in other clinical trials involving AK120 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of moderate to severe atopic dermatitis, offering relief to patients who have not responded well to existing therapies.

How similar studies have performed: Other studies have shown promise in treating atopic dermatitis with similar biologic approaches, indicating potential for success with AK120.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female subjects aged ≥18≤75 years old.
2. Atopic dermatitis (AD) diagnosed at least 1 year before screening.
3. Subject with eczema area and severity index (EASI) score ≥16, Investigator Global Assessment (IGA) score≥ 3, Body Surface Area (BSA) score ≥ 10% at screening and baseline.
4. Previously received at least 4 weeks of moderate to strong or at least 2 weeks of strong local glucocorticoid (TCS) treatment for AD before screening, with poor efficacy or intolerable

Exclusion Criteria:

1. Acute onset of AD within the first 4 weeks of randomization.
2. Have participated in any clinical research on AK120 in the past
3. Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
4. Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
5. Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
6. Received allergen specific immunotherapy within the 3 months before randomization.
7. Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.

Where this trial is running

Beijing, Beijing and 58 other locations

+9 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic Dermatitis
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.